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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-119 Complete IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
06/07/2021 Radiology 12-338 Complete IEC 60601-2-1 Edition 4.0 2020-10 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
09/17/2018 Biocompatibility 2-255 Complete ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
09/17/2018 Biocompatibility 2-256 Complete ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
12/23/2019 Radiology 12-309 Complete IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
06/07/2018 Biocompatibility 2-250 Complete ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
06/27/2016 Radiology 12-301 Complete IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
06/07/2018 General Plastic Surgery/
General Hospital		 6-405 Complete IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
12/21/2020 General I (QS/
RM)		 5-131 Complete IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)]
05/29/2023 Radiology 12-347 Complete IEC 60601-2-33 Edition 4.0 2022-08 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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